"It is a biologic. Period "- I don't agree with that portion, given the CELTEX warning letter, which IMO is pretty clear, but it's OK if that's one's viewpoint. No sweat.
But the rest of the statement is finer- much clearer. So the key argument/theory is that via this "biologic" arm/division versus I guess a pure "drug" aka pharma for example, it's being argued that the trial enrollment will be less (less people, as in say 200 versus a theoretical 1000 or something for example) and thus "somewhat" perhaps less costly? Fine, that's a viewpoint and I can respect that.
I've seen however, major "drug/pharma" products (pick one- say an antidepressant or something), and if I remember correctly (I'll do some checking) I don't remember the trials (phase III) being 1000 people/enrollees or anything of that nature? In fact one of my own gripes for lack of better word with FDA approval of some of these, IMO controversial, "drugs", is that when one looks carefully at the trial(s) that got um approved, I'm often stunned how FEW people were in them (maybe 200 as a sample that's supposed to be statistically representative of an entire population- say 300 million people in the U.S.) and that they maybe at best, often lasted 6, maybe 8 weeks or something- which is a joke IMO, when trying to determine if some brain altering drug is "safe" or even what the heck it actually does, or what its long term side effects are even short term, let alone mid-term and long term, etc.
So, I'm not really familiar with this premise of a "drug" trial leading into the 1000 patients size and a "biologic" being much smaller and thus I guess "simpler" or at least less costly? I'll look into it more.
Bottom line to me, again, is phase III through the FDA, no matter how one wants to slice it- is a daunting, expensive (massively expensive IMO) and usually long, complicated and drawn out process and tough as all get out to get an approval. Given all the evidence of even mega big companies that get a large number of their products rejected every single yr by the FDA, I don't know how that can be disputed?
And I'm not saying I'm any huge fan of the FDA and a believer in exactly what they do and how they do it or if they're really even always serving the best interest of the public at large anymore. It's just that for now- they're the law of this land (Euro has a pretty similar law of their land) and thus anyone wanting to play in this arena of a biz undertaking pretty much lives and dies by the ole FDA. Sometimes sad, but true. They have the long arm of the Federal govt tied to um- so their enforcement powers and abilities don't get much more powerful IMO. Again, not even saying that's necessarily a good thing anymore, just the way it is.
AI
